Director Medical Writing Submission Facilitator

Site Name: Wavre, Italy – Siena, Mississauga
Posted Date: Aug 30 2024

GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and AI/ML.

Job Purpose

The Director Medical Writing Submission Facilitator would be responsible to facilitate the GSK submission hyper-acceleration ambition by being a strong advocate and change champion for ensuring the medical writing driven acceleration levers and hyper acceleration technology are embedded and utilized optimally ensuring Medical Writing (MW) hyper-acceleration ambition deliverables are delivered to time and quality by applying expert leadership, scientific and operational expertise and strong influential skills.

Key Responsibilities:

• Partners with the MW LT and MW Submission leads in developing, driving, implementing and embedding accelerations levers in a multi-cultural, cross-functional, and cross-Therapy Area setting including senior stakeholders.
• Be a change champion and strong advocate for embedding and utilizing Acceleration Levers and relevant Hyper Acceleration technology in the hyper-acceleration ambition submission teams in a multi-cultural, cross-functional, and cross Therapy Area setting including senior stakeholders.
• Leads, drives and promotes MW acceleration strategy and represents MW in hyper-acceleration ambition submission forums such as the Acceleration Squad Meetings.
• Proactively generates ideas for simplification and improvement in the area of hyper-acceleration ambition submissions.
• Builds interactive relationships with Functional leads and senior stakeholders in the context of acceleration.
• Removes blockers to hyper-acceleration ambition submission acceleration and escalates issues.
• Ensures relevant stakeholder management in close collaboration with the MW Head, MW Head of H&E and Medical Writing TA Heads.
• Highly pragmatic with strong negotiation skills.
• Facilitates execution of agreed timelines for the clinical submission document within the remit of Medical Writing in close collaboration with the Medical Writing Submission Lead and Submission Medical Writer Lead Authors.
• Promotes agility in ways of working within submission teams.
• Ensures submission teams are trained in the MW owned acceleration levers and Hyper Acceleration technology.
• Ability to oversee and support multiple hyper-acceleration ambition submission teams in parallel.

Basic Qualifications:

• PhD degree in Life Science/ Health Science or equivalent.
• Extensive years of experience in clinical submissions dossier work as an SME – corresponding to Director/Program Lead – in a global Pharma R&D or CRO setting with a profound understanding of the clinical development process and phases of development.
• Demonstrated influential skills in a fast-paced, high-pressure multi-cultural environment.
• Track-record of delivering business outcomes and value and simplification with a passion for science and advancing medicines to patients.
• Experience in multicultural settings, diverse environments with respect to dynamics of human interaction.
• Excellent strategic, planning and organizational skills.
• Excellent interpersonal skills.
• Strong problem-solving and negotiation skills.
• Highly structured and diligent.
• Relentless for delivering business outcomes and value and simplification with a passion for science and advancing medicines to patients.
• Excellent communication skills in verbal and written English.

Preferred Qualifications:

• Being able to navigate a complex matrix organisation with an ability to partner with, and influence, senior stakeholders across the company.

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